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New requirements for medical devices

At MT-Connect, to be held in Nuremberg from 11 to 12 April 2018, TÜV SÜD will inform on how the Medical Device Regulation (MDR) will impact on medical device manufacturers. The Medical Device Single Audit Program (MDSAP) will be a further important topic at the company’s stand. TÜV SÜD's experts will also inform about testing and certification of medical devices – in particular for global market access (GMA) (Hall 10, Stand 323).

The new EU Medical Device Regulation (MDR) replaces Directives 93/42/EEC on medical devices (MDD) and 90/385/EEC on active implantable medical devices (AIMD). Given this, all manufacturers of medical devices in classes I to III now need to address the new requirements in a timely manner. For the first time, the Medical Device Regulation (MDR) also includes requirements for products that are not medical devices per se. Changes concern classification of products, the essential requirements applicable so far, technical documentation, clinical data, post-market surveillance and the quality management system. “Manufacturers need to prepare now and coordinate their approach with a Notified Body to manage the transition successfully and ensure compliance with the requirements of the new MDR”, says Norbert Stuiber, TÜV SÜD.

TÜV SÜD's medical device professionals can offer valuable support: With over 600 staff worldwide, they always have up-to-date and detailed knowledge of the requirements in the respective target markets. Manufacturers benefit from both their technical expertise and their extensive range of international accreditations (INMETRO, NRTL, MDSAP). This considerably reduces the efforts involved in accessing the markets of many countries. On top of this, TÜV SÜD's local medical-device professionals and testing experts ensure compliance with the required safety and quality standards, provide problem-free handling of the necessary test methods and can slash cost-intensive design and development periods.

TÜV SÜD also carries out audits within the scope of the Medical Device Single Audit Program (MDSAP). The MDSAP, a project of the International Medical Device Regulators Forum (IMDRF), offers the possibility of ensuring compliance with the regulatory requirements of several countries – Australia, Brazil, Japan, Canada and the USA – with a single quality management audit. TÜV SÜD was among the first organisations authorised within the scope of the program and has carried out MDSAP audits since 2014. Medical device manufacturers can also benefit from the company’s wealth of special experience, which the experts will present in greater detail at the trade fair.

In addition to the experts' presence at the trade fair stand, Dr Susanne Gerbl-Rieger, Director of Clinical Audit at the Clinical Centre of Excellence of TÜV SÜD Product Service GmbH, will give a talk on clinical investigation and clinical evaluation of medical devices from the point of view of the Notified Body. The talk will be held on Thursday 12 April 2018 at 11:10 am as part of the MedTech Summit.

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